Boris Schmidt

Background: Deep sedation (DS) is routinely used during single‐shot pulmonary vein isolation (PVI) to optimize patient comfort and procedural stability. However, data on sedative requirements and procedural tolerance of pulsed field ablation (PFA) under DS compared with thermal technologies remain limited. Methods: In this single‐center study, consecutive patients underwent PVI with cryoballoon (CB), PFA using a pentaspline catheter (PC) or the balloon‐in‐basket catheter (BC). All procedures were performed under DS with midazolam, fentanyl, and propofol, administered by electrophysiology staff without anaesthesiologist supervision. Propensity score matching (1:1:1) was applied for age, sex, body mass index, and hypertension. Procedural characteristics, sedative/analgesic requirements, and complications were analyzed. Results: Acute PVI without major complications was achieved in all 156 enrolled patients. PC procedures were associated with higher body‐weight‐ and time‐adjusted requirements for propofol (CB: 0.10 ± 0.04 mg/kg/min; PC: 0.15 ± 0.04 mg/kg/min; BC: 0.11 ± 0.03 mg/kg/min; p < 0.001) despite the lowest total dose of propofol used (CB: 440 ± 144 mg; PC: 348± 80 mg; BC: 433 ± 160 mg; p = 0.00). Procedural times (CB: 47.5 [40–60] min, PC: 29 [25–35] min, BC: 47.5 [40–56] min, p < 0.001) and fluoroscopy times (CB: 9.5 [6.3–13.6] min; PC: 6.2 [4.4–9] min; BC: 7.2 [6.1–11.2] min, p = 0.001) were shortest in the PC group. Sedation‐related hemodynamic stability was comparable across all cohorts. Conclusions: The novel BC demonstrated excellent feasibility under DS, with reduced normalized sedative requirements compared with the PC and a safety profile comparable to CB ablation. These findings suggest that optimized waveform design and field homogeneity may enable safe and comfortable PVI under DS without the need for general anesthesia.

Background: Immune checkpoint inhibitor (ICI)-associated myocarditis is a rare but potentially fatal immune-related adverse event that may present with conduction abnormalities, ventricular arrhythmias, cardiogenic shock, and sudden cardiac death. The risk is increased with combined programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blockade. We report a fatal case of fulminant ICI-associated myocarditis following combined nivolumab and ipilimumab therapy. Case Presentation: A 79-year-old man with metastatic clear-cell renal cell carcinoma developed progressive fatigue and exertional dyspnea 14 days after his first and only cycle of nivolumab and ipilimumab. Electrocardiography revealed complete atrioventricular block. High-sensitivity cardiac troponin T increased from 2575 to 11,327 pg/mL, whereas creatine kinase initially decreased from 8690 U/L before rising again. Coronary angiography excluded obstructive coronary artery disease. Temporary transvenous pacing was followed by permanent pacemaker implantation. Despite intensive care, the patient developed progressive hemodynamic deterioration requiring vasopressor support and ultimately fatal cardiorespiratory collapse. ICI-associated myocarditis was not recognized during life; therefore, no myocarditis-directed diagnostic work-up or immunosuppressive treatment was initiated. Post-mortem examination demonstrated pronounced diffuse lymphohistiocytic myocarditis involving both atria and ventricles. ICI-associated myocarditis was identified as the cause of death, with a concomitant retroperitoneal abscess with pancreatic fistulation considered an aggravating condition. Conclusions: Complete atrioventricular block accompanied by a marked dynamic troponin increase should raise suspicion of ICI-associated myocarditis, particularly after exclusion of obstructive coronary artery disease. In this case, the diagnosis was established only post mortem. Earlier recognition of this clinical constellation may facilitate timely myocarditis-directed diagnostic evaluation and treatment.

The aim of the AFA-ARC (Atrial Fibrillation Ablation Academic Research Consortium) initiative is to reexamine trial design and the safety and effectiveness end points for pivotal clinical trials evaluating catheter ablation for the treatment of symptomatic atrial fibrillation to provide meaningful and interpretable data to support regulatory decision-making. Beginning in July 2024, a group of international experts began meeting regularly both virtually together and separately in working groups (group 1 effectiveness end points; group 2 safety end points; and group 3 trial design and report forms), with one in-person meeting held in April 2025, and revisions of draft proposals from January 2025 to February 2026. The Food and Drug Administration Office of Cardiovascular Devices at the Center for Devices and Radiological Health provided input throughout the revision and proposal process. A patient advocate participated in the in-person meeting and during the revision phase. Heart Rhythm Society leadership was involved throughout the process and in the revision phase. Industry representatives were sent drafts of the proposed manuscripts during the revision phase before submission. The result of this process was the creation of a combined document to reexamine trial design and the safety and effectiveness end points for pivotal clinical trials evaluating catheter ablation of atrial fibrillation. This document represents contributions from each of the 3 Working Groups. The Heart Rhythm Society endorsed this document. This AFA-ARC document proposes revised effectiveness and safety end points, study design, and report forms for studies evaluating AF ablation in patients with symptomatic paroxysmal, persistent, or longstanding persistent AF.

Aims: Patients with left atrial appendage (LAAO) devices are increasingly referred for atrial fibrillation (AF) ablation, yet anticoagulation strategies remain uncertain. The goal of this study was to evaluate the safety and efficacy of catheter ablation for AF in patients with pre-existing LAAO devices and to describe patterns in anticoagulation management after ablation in this unique population. Methods and results: We collected data from 14 centres worldwide on patients with prior LAAO devices undergoing AF ablation. Each site provided clinical characteristics, procedural details, and information on complications and arrhythmia outcomes. Data were aggregated and analysed centrally to evaluate procedural safety, efficacy, and variability in management strategies. A total of 198 patients (age 70 years, 37% female, 42% paroxysmal AF) with prior LAAO were included. Ablation was performed a median of 271 days after LAAO. After ablation, 84% of patients were on oral anticoagulation (OAC), most commonly for 2–3 months. Bleeding complications on OAC occurred in 6.7% of patients at a median of 20 (13, 70) days after ablation. Stroke or TIA occurred in five patients (2.6% of cases) within the follow-up period with two occurrences (1% of cases) the day after ablation. There were two cases of new or worsened peri-device leak after ablation. Conclusion: In a large, international registry of patients undergoing catheter ablation for AF with pre-existing LAAO devices, ablation was feasible, and device related complications were rare. Despite higher bleeding risk in an LAAO population, 84% of patients with prior LAAO tolerated short-term OAC post-ablation with bleeding events at expected rates for this population.